Wrinkles Clinical Trial
Official title:
Clinical Evaluation of Silk'n HST Self-selection, Labeling Comprehension, and Device Use
This is a Usability study, conducted for the purpose of testing Silk'n HST Device usability.
Study objectives:
To test the Silk'n HST Device usability, i.e., the self-selection, labeling comprehension,
and safe and effective device use by potential end users, under actual use conditions.
Additionally, this study was aimed to evaluate if contraindicated subjects self-exclude from
use of the device.
Investigation Design:
The study is a usability study. Twenty five potential participants were enrolled in a single
location (shopping mall). Participants received the Silk'n HST device in its original package
with the complete user manual and performed a full treatment. Post-treatment questionnaire
and labeling comprehension exam were conducted following treatment. Out of the twenty five
subjects five participants contraindicated to the study inclusion criteria were self-exclude
from use of the device.
Success criteria:
Using the device, all 20 tested subjects are able to complete device related tasks, including
applying and operating the Silk'n device without assistance in a timeframe of up to one hour
and with minimal attempts to ask for assistance.
Additionally, measurable usability criteria for specific, critical steps, such as
time-to-completion, frequency of attempts to ask examiner, numerical ratings, etc., were
evaluated using observer evaluation and user post-test questionnaire responses.
Sample Size:
Twenty five subjects identified as potential end users of the device including five subjects
with contraindication to the device were recruited to the study. The number of subjects is
appropriate considering the device and user related risks, low probable occurrence and
severity of these risks, and the design of the study. Furthermore, usability studies are not
seeking statistical significance.
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